Srivastava 2019.
Study characteristics | ||
Methods |
Study design: randomised clinical trial (single‐blinded, parallel group) conducted in India. Participants as the unit of randomisation. Duration of the study: May 2017 to April 2018 Follow‐up time: 24 weeks (intermediate‐term follow‐up) Protocol was published before recruitment of participants: not reported. The study protocol was approved by the institutional Screening Committee and Ethics Committee. Informed consent was obtained from all the participants. Details of trial registration: not reported Funding sources: none declared |
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Participants |
Number of participants assigned: 60 participants (with a total of 60 scars treated ‐ 1 scar per participant). Group 1(fractional CO2 laser): 20 participants Group 2(intralesional TAC): 20 participants Group 3(intralesional verapamil): 20 participants Loss: none. Number of participants assessed: 60 participants Group 1: 20 individuals Group 2: 20 individuals Group 3: 20 individuals Inclusion criteria:
Exclusion criteria:
Participants Age (years): Group 1: 32.65 / 9.74 (mean / %) Group 2: 30.45 / 9.33 (mean / %) Group 3: 29.45 / 8.24 (mean / %) Gender: Group 1: male: 9; 45 (number; %); female: 11; 55 (number; %) Group 2: male: 11; 55 (number; %); female: 9; 45 (number; %) Group 3: male: 9; 45 (number; %); female: 11; 55 (number; %) Scar Location: Group 1: extremity: 5; 25 (number; %); face: 4; 20 (number; %); trunk: 4; 20 (number; %); presternal: 7; 35 (number; %) Group 2: extremity: 4; 20 (number; %); face: 2; 10 (number; %); trunk: 6; 30 (number; %); presternal: 8; 40 (number; %) Group 3: extremity: 4; 20 (number; %); face: 3; 15 (number; %); trunk: 4: 20 (number; %); presternal: 9; 45 (number; %) Scar Aetiology: Group 1: burn: 6; 30 (number; %); infection: 6; 30 (number; %); surgery: 3; 15 (number; %); trauma: 5; 25 (number; %) Group 2: burn: 5; 25 (number; %); infection: 6; 30 (number; %); surgery: 3; 15 (number; %); trauma: 6; 30 (number; %) Group 3: burn: 4; 20 (number; %); infection: 5; 25 (number; %); surgery: 4; 20 (number; %); trauma: 7; 35 (number; %) |
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Interventions |
Group 1: fractional CO2 laser was delivered with a spot density of 25 spots/cm2 and energy of 30–50 millijoules level, every 3 weeks, for 24 weeks. Group 2: intralesional TAC (a maximum of 2 mL of 40 mg/mL) was injected every 3 weeks for 24 weeks or till scar flattening occurred, whichever was earlier. Group 3: intralesional Verapamil (a maximum of 2 mL of 2.5mg/mL) was injected every 3 weeks for 24 weeks or till scar flattening occurred, whichever was earlier. |
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Outcomes |
Primary outcomes: Vancouver Scar Scale (VSS): For VSS, keloid height was measured with callipers; pliability was assessed by palpation; vascularity was assessed by visual inspection; and pigmentation was scored after blanching and comparing it with the surrounding skin. Blanching was achieved using a piece of clear plastic sheet till scar flattening occurred (VSS < 2). Treatment‐related adverse effects: Pain at injection site, telangiectasia, skin atrophy and charring were evaluated and reported (when they occurred). Secondary Outcomes: Change in scar pruritus: method not described. Change in scar pain: method not described. Change in scar height: measured with callipers. Change in scar pliability: assessed by palpation. Change in scar vascularity: assessed by visual inspection. Change in scar pigmentation: scored after blanching and comparing it with the surrounding skin. Scars were evaluated at each stage by taking serial photographic records and objective measurements by VSS. Assessment was done by a resident doctor who was not part of the treating team. Mean values of the score were recorded. |
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Notes | Comparative analysis among the 3 groups was done using scatter plots to determine the correlation in the treatment groups. Proportions were compared between the groups using chi square test and ANOVA was used for evaluating difference in means of groups. Statistical analysis was carried out with SPSS software for Windows Version 23.0 (Armonk, NY). A P value of < 0.05 was considered to be significant. Funding sources: none declared. The authors declare that no competing financial interests exist. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "All the patients eligible for the study were selected from the outpatient clinic and randomised according to the Chit‐in‐Box method". |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Single‐blinded study. Participants and health professionals performing the treatment were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Assessment was done by a resident doctor who was not part of the treating team". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the study. |
Selective reporting (reporting bias) | Unclear risk | No trial protocol is available. All parameters listed to assess changes in the scars were described (although methods used to assess pruritus and pain have not been described). |
Other bias | Low risk | No other sources of bias were found. |